MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GX-770; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number GX-770

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

The device "suspection" arm failed and made contact with the patient's face.The impact to the patient is not known at the time of this report.No serious injury has been reported.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation at the time of this report.The impact to the patient was not made available to the manufacturer; however, no serious injury was reported.A follow-up report will be submitted upon completion of the device evaluation and/or if new information becomes available regarding the impact to patient.Device not returned to manufacturer.

Manufacturer Narrative

The device was manufactured in 2009 and had been in continuous operation for 6 years.The suspect device was received for evaluation on 14-apr-2015.Visual inspection revealed that the brass spring union attaching the tension spring to the fulcrum was broken in two.A complaint investigation was performed and no trend could be identified for similar field failures within the estimated life expectancy of 7 years.The device user manual states that a maintenance program must be established in the interest of equipment safety.No evidence of routine maintenance is available and the lack of routine maintenance may likely have contributed to the device failure.This concludes our investigation.

• Brand Name: GX-770
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): GENDEX DENTAL SYSTEMS; 901 west oakton st.; des plaines IL 60018 188
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 4656694
• MDR Text Key: 5680480
• Report Number: 2530069-2015-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: GX-770
• Device Catalogue Number: 0.820.0146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1